The present invention relates to the diagnosis and treatment of stress urinary incontinence. In one embodiment, the diagnosis and treatment involves the use of a positional feedback catheter. Positional sensors may be embedded in the catheter to provide real-time tracking of the position and movement of the catheter.
Stress urinary incontinence (SUI), also known as effort incontinence, is due essentially to the insufficient strength of the pelvic floor muscles, which leads to the most common etiology of SUI, namely hypermobility of the bladder neck. SUI may present the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other movements that increase intra-abdominal pressure and thus increase pressure on the bladder. The urethra is supported by fascia of the pelvic floor. If this support is insufficient, the urethra can move downward at times of increased abdominal pressure, allowing urine to pass.
In women, physical changes resulting from pregnancy, childbirth, and menopause often contribute to stress incontinence. Stress incontinence can worsen during the week before the menstrual period. At that time, lowered estrogen levels may lead to lower muscular pressure around the urethra, increasing chances of leakage. The incidence of stress incontinence increases following menopause, similarly because of lowered estrogen levels. In female high-level athletes, effort incontinence occurs in all sports involving abrupt repeated increases in intra-abdominal pressure that may exceed perineal floor resistance.
It is thought that the principal cause of stress urinary incontinence (SUI) is pregnancy and childbirth and the consequent tearing of the tissues that support the bladder and urethra.
In an attempt to correct this defect, various surgeries have been devised, all with the intent of repositioning the bladder and urethra to their proper place by either a vaginal or abdominal surgical approach. These surgical connections would be highly successful if the bladder and bladder neck could be restored to their natural position. Unfortunately, current surgeries have the high failure rate of approximately 60% due to the lack of a definitive way of checking whether the positioning is correct during any of the surgeries.
Currently, the surgeon pulls the bladder neck into an approximate position, usually through the vaginal wall. The position is approximate because the surgeon cannot actually see, and thus must assume, through experience, the correct position.
This guess is later confirmed correct or incorrect through the passage of time and or the willingness of the patient to complain about the SUI or the recurrence of the SUI, in which case, the patient would be subjected to yet another possibly unsuccessful surgery.
Each time a surgery is performed there is an increased amount of scar tissue. The general immobilization of the tissues will increase after subsequent surgeries, which will adversely affect the subsequent success/failure rate of these surgeries. There is a genuine need for the surgeon to be able to watch the bladder and its position in real time as the surgery progresses in order to avoid more surgeries and to correct the SUI during the initial procedure.
By watching the positioning in real time, the surgeon would be able to position the bladder neck and the urethra correctly and not have to guess at the proper placement. It would no longer be a blind procedure leaving the bladder too tight or at times too loose or subject to the happenstance of a correct positioning.
One of the most accurate tools currently available for diagnosing urinary incontinence is a cystourethrogram. The diagnoses of urinary incontinence using this method are based on difficult to interpret pressure variants, which may lead to misdiagnoses of SUI versus urge incontinence versus neurological defect. Often, presently available diagnostic methods test the patient in the dorso lithotomy position during which time stress urinary incontinence does not occur. Rather, a patient should be tested instead under the same event that causes incontinence, such as coughing, running, jumping, etc., making the diagnosis of the etiology more accurate by monitoring the mobilization of the patient's pelvic floor during the event that causes the incontinence.